Brain TumorNCT01944761
The Neuro-protective Effects of Exercise in Children With Brain Tumors
A study testing Exercise Program in people with Brain Tumor, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
The objectives of our proposed study are to (a) evaluate the feasibility of conducting a structured exercise program in children treated with cranial radiation for brain tumors, (b) test whether exercise results in improved thinking skills and emotional function, and (c) examine potential mechanisms of improved… Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Brain Tumor
- What is being tested?
- Exercise Program
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteCanada
- Study dates
- 3 Feb 2011to 16 Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Survivors will be included if they are between 7 and 17 years of age.
- Survivors will be included if they either declare English as their native language or have had at least two years of schooling in English at the time of their first assessment.
- Survivors must have been diagnosed with a hemispheric or posterior fossa tumor and been treated with cranial spinal radiation.
- Survivors no more than 10 years may have elapsed between diagnosis and time of study.
- Survivors with a shunt will be included in the study, but will need to be identified prior to study on-set to discuss any specific considerations for imaging and physical activity.
Who cannot join
- are younger than 7 years (the delivery of an intervention program to young children carries challenges that make it difficult to include in an initial feasibility grant) or older than 17 years
- require sedation for MRI imaging
- is claustrophobic
- have severe neurological/motor dysfunction that would preclude safe participation in an exercise program.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Neuro-protective Effects of Exercise in Children Treated With Cranial Radiation for Brain Tumors
The objectives of our proposed study are to (a) evaluate the feasibility of conducting a structured exercise program in children treated with cranial radiation for brain tumors, (b) test whether exercise results in improved thinking skills and emotional function, and (c) examine potential mechanisms of improved outcome, particularly recovery of white matter and grey matter.
Read the detailed description
Brain tumors are the leading cause of death and disability from childhood disease in developed countries. With treatment advances over the last 25 years, survival rates have improved dramatically. However, survival is often achieved at considerable cost. Cranial radiation is frequently required for effective tumor control, and is associated with significant neuro-toxicity, including white matter damage and cognitive morbidity. In order to achieve the best possible outcome for survivors, and ultimately conquer the long-term consequences of this disease, new interventions must be developed to ameliorate the neuro-toxic effects experienced by children. radiation injury can now be used to guide the development of interventions designed to rescue neural tissue. Furthermore, various new agents and activities with potential to stimulate neuro-recovery are now available. The potential value of exercise for rescuing the brain from neuro-toxic effects, for instance, has recently been reported. Next, neuro-cognitive processes that are particularly sensitive to the effects of cranial radiation have been identified and can serve as behavioral assays to test the effectiveness of these new interventions. Finally, novel neuro-imaging tools are available to perform in vivo evaluations in order to delineate potential mechanisms of neuro-recovery. We intend to integrate these new research findings to develop and evaluate a physical exercise-based intervention targeted at rescuing brain tissue of children with brain tumors from the neuro-toxic impact of cranial radiation.
- Conditions
- Brain Tumor
- Being tested
- Exercise Program
- Keywords
- Pediatrics, Brain Tumor, Neuro-radiation, Exercise
- Medical subject headings
- Brain Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise ProgramBehavioural
Designed to improve cardio-respiratory fitness, the exercise program will be conducted for 12 weeks at a frequency of 3-4 sessions per week. Each exercise session will be conducted after school for a total duration of 90 minutes (group sessions) or 30 minutes (home-based sessions). Group session activities will include i) warm-up (i.e. walk/jog, games) [10 mins], ii) aerobic training/fitness games [30 mins], iii) organized sports [30 mins], iv) cool down (i.e. stretching, low intensity games) [10 mins] and v) snack and reward (15 mins).
Participants in the Group setting had three 90-minute group sessions per week. Participants in the Combined setting had two 90-minute group sessions and two 30-minute individual home-based sessions per week.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Training | Experimental | The 16 participants in this group will be quasi-randomized based on the order of recruitment to start the 12 week exercise intervention without delay (immediate condition). Receives: Behavioral: Exercise Program |
| Delayed Exercise Training | Experimental | The 16 participants in this group will be quasi-randomized based on the order of recruitment to start the 12 week exercise intervention after a 12 week no exercise training period (delayed condition). Receives: Behavioral: Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of implementing an excercise intervention
We will look at several factors, including recruitment rate, exercise adherence rate, retention rate and participant/parent satisfaction to determine the feasability of this intervention
Measured: At week 42-45
Secondary outcomes (3)
Fitness
Fitness will be measured using the volume of oxygen consumed while exercising at maximum capacity (VO2max) on a stationary bicycle.
Measured: Baseline, once at week 26-29 and once at week 42-45
Neuro-cognitive outcome
Three neuro-cognitive processes important for cognitive development, and found to be sensitive to radiation injury, will be assessed. These measures of cognition include attention, information processing speed, and declarative memory.
Measured: Baseline, once at week 26-29 and once at week 42-45
Neural recovery (gliogenesis/neurogenesis)
Changes in white matter integrity may occur as a result of gliogenesis and will be measured using Diffusion Tensor Imaging (DTI). Neurogenesis occurs primarily within the hippocampus, a structure important for learning a memory. Cerebral blood flow (CBF) has been demonstrated to be a potential surrogate imaging measure of neurogenesis. As such, we will use Arterial Spin Labeled (ASL) perfusion MRI to obtain estimates of CBF within the hippocampus.
Measured: Baseline, once at week 26-29 and once at week 42-45
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2013 (estimated)
- Study start3 Feb 2011
- Primary completion16 Mar 2015
- Study completion16 Mar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Donald Mabbott, The Hospital for Sick Children
- Investigators
- Donald Mabbott, PhD, Principal investigator, The Hospital for Sick Children, Toronto Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01944761
- Sponsor's protocol ID
- 1000019124
- Status last verified
- Sep 2026
- First submitted
- 15 Aug 2013
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Szulc-Lerch KU, Timmons BW, Bouffet E, Laughlin S, de Medeiros CB, Skocic J, Lerch JP, Mabbott DJ. Repairing the brain with physical exercise: Cortical thickness and brain volume increases in long-term pediatric brain tumor survivors in response to a structured exercise intervention. Neuroimage Clin. 2018 Mar 5;18:972-985. doi: 10.1016/j.nicl.2018.02.021. eCollection 2018.
PubMed 29876282Piscione PJ, Bouffet E, Timmons B, Courneya KS, Tetzlaff D, Schneiderman JE, de Medeiros CB, Bartels U, Mabbott DJ. Exercise training improves physical function and fitness in long-term paediatric brain tumour survivors treated with cranial irradiation. Eur J Cancer. 2017 Jul;80:63-72. doi: 10.1016/j.ejca.2017.04.020. Epub 2017 May 25.
PubMed 28551430Riggs L, Piscione J, Laughlin S, Cunningham T, Timmons BW, Courneya KS, Bartels U, Skocic J, de Medeiros C, Liu F, Persadie N, Scheinemann K, Scantlebury N, Szulc KU, Bouffet E, Mabbott DJ. Exercise training for neural recovery in a restricted sample of pediatric brain tumor survivors: a controlled clinical trial with crossover of training versus no training. Neuro Oncol. 2017 Mar 1;19(3):440-450. doi: 10.1093/neuonc/now177.
PubMed 27555603Cox E, Bells S, Timmons BW, Laughlin S, Bouffet E, de Medeiros C, Beera K, Harasym D, Mabbott DJ. A controlled clinical crossover trial of exercise training to improve cognition and neural communication in pediatric brain tumor survivors. Clin Neurophysiol. 2020 Jul;131(7):1533-1547. doi: 10.1016/j.clinph.2020.03.027. Epub 2020 Apr 13.
PubMed 32403066Baudou E, Ryan JL, Tseng J, Bouffet E, Bartels U, Timmons BW, de Medeiros CB, Mabbott DJ. Repairing Myelin After Irradiated Pediatric Brain Tumor: A Magnetization Transfer Imaging Analysis. Pediatr Blood Cancer. 2025 Sep;72(9):e31838. doi: 10.1002/pbc.31838. Epub 2025 Jun 14.
PubMed 40515500Baudou E, Ryan JL, Cox E, Nham L, Johnston K, Bouffet E, Bartels U, Timmons B, de Medeiros C, Mabbott DJ. Optimizing an exercise training program in pediatric brain tumour survivors: Does timing postradiotherapy matter? Neurooncol Pract. 2023 Sep 9;11(1):69-81. doi: 10.1093/nop/npad055. eCollection 2024 Feb.
PubMed 38222057
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Neuro-protective Effects of Exercise in Children Treated With Cranial Radiation for Brain Tumors
- ClinicalTrials.gov ID
- NCT01944761
- Acronym / sponsor ID
- 1000019124
- Conditions
- Brain Tumor
- Keywords
- Pediatrics, Brain Tumor, Neuro-radiation, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 3 Feb 2011 (actual)
- Primary completion
- 16 Mar 2015 (actual)
- Study completion
- 16 Mar 2015 (actual)
- First posted
- 18 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of our proposed study are to (a) evaluate the feasibility of conducting a structured exercise program in children treated with cranial radiation for brain tumors, (b) test whether exercise results in improved thinking skills and emotional function, and (c) examine potential mechanisms of improved outcome, particularly recovery of white matter and grey matter.
Detailed description
Brain tumors are the leading cause of death and disability from childhood disease in developed countries. With treatment advances over the last 25 years, survival rates have improved dramatically. However, survival is often achieved at considerable cost. Cranial radiation is frequently required for effective tumor control, and is associated with significant neuro-toxicity, including white matter damage and cognitive morbidity. In order to achieve the best possible outcome for survivors, and ultimately conquer the long-term consequences of this disease, new interventions must be developed to ameliorate the neuro-toxic effects experienced by children. radiation injury can now be used to guide the development of interventions designed to rescue neural tissue. Furthermore, various new agents and activities with potential to stimulate neuro-recovery are now available. The potential value of exercise for rescuing the brain from neuro-toxic effects, for instance, has recently been reported. Next, neuro-cognitive processes that are particularly sensitive to the effects of cranial radiation have been identified and can serve as behavioral assays to test the effectiveness of these new interventions. Finally, novel neuro-imaging tools are available to perform in vivo evaluations in order to delineate potential mechanisms of neuro-recovery. We intend to integrate these new research findings to develop and evaluate a physical exercise-based intervention targeted at rescuing brain tissue of children with brain tumors from the neuro-toxic impact of cranial radiation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Training | Experimental | Behavioral: Exercise ProgramThe 16 participants in this group will be quasi-randomized based on the order of recruitment to start the 12 week exercise intervention without delay (immediate condition). |
| Delayed Exercise Training | Experimental | Behavioral: Exercise ProgramThe 16 participants in this group will be quasi-randomized based on the order of recruitment to start the 12 week exercise intervention after a 12 week no exercise training period (delayed condition). |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Survivors will be included if they are between 7 and 17 years of age.
- Survivors will be included if they either declare English as their native language or have had at least two years of schooling in English at the time of their first assessment.
- Survivors must have been diagnosed with a hemispheric or posterior fossa tumor and been treated with cranial spinal radiation.
- Survivors no more than 10 years may have elapsed between diagnosis and time of study.
- Survivors with a shunt will be included in the study, but will need to be identified prior to study on-set to discuss any specific considerations for imaging and physical activity.
Key exclusion criteria (4 listed)
- are younger than 7 years (the delivery of an intervention program to young children carries challenges that make it difficult to include in an initial feasibility grant) or older than 17 years
- require sedation for MRI imaging
- is claustrophobic
- have severe neurological/motor dysfunction that would preclude safe participation in an exercise program.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise ProgramDesigned to improve cardio-respiratory fitness, the exercise program will be conducted for 12 weeks at a frequency of 3-4 sessions per week. Each exercise session will be conducted after school for a total duration of 90 minutes (group sessions) or 30 minutes (home-based sessions). Group session activities will include i) warm-up (i.e. walk/jog, games) [10 mins], ii) aerobic training/fitness games [30 mins], iii) organized sports [30 mins], iv) cool down (i.e. stretching, low intensity games) [10 mins] and v) snack and reward (15 mins). Participants in the Group setting had three 90-minute group sessions per week. Participants in the Combined setting had two 90-minute group sessions and two 30-minute individual home-based sessions per week. | Behavioural | Delayed Exercise Training, Exercise Training |
Primary outcome
Feasibility of implementing an excercise intervention
Time frame: At week 42-45
We will look at several factors, including recruitment rate, exercise adherence rate, retention rate and participant/parent satisfaction to determine the feasability of this intervention
3 secondary outcomes
Fitness
Time frame: Baseline, once at week 26-29 and once at week 42-45
Neuro-cognitive outcome
Time frame: Baseline, once at week 26-29 and once at week 42-45
Neural recovery (gliogenesis/neurogenesis)
Time frame: Baseline, once at week 26-29 and once at week 42-45
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Results publication: PubMed 29876282Szulc-Lerch KU, Timmons BW, Bouffet E, Laughlin S, de Medeiros CB, Skocic J, Lerch JP, Mabbott DJ. Repairing the brain with physical exercise: Cortical thickness and brain volume increases in long-term pediatric brain tumor survivors in response to a structured exercise intervention. Neuroimage Clin. 2018 Mar 5;18:972-985. doi: 10.1016/j.nicl.2018.02.021. eCollection 2018.
- Results publication: PubMed 28551430Piscione PJ, Bouffet E, Timmons B, Courneya KS, Tetzlaff D, Schneiderman JE, de Medeiros CB, Bartels U, Mabbott DJ. Exercise training improves physical function and fitness in long-term paediatric brain tumour survivors treated with cranial irradiation. Eur J Cancer. 2017 Jul;80:63-72. doi: 10.1016/j.ejca.2017.04.020. Epub 2017 May 25.
- Results publication: PubMed 27555603Riggs L, Piscione J, Laughlin S, Cunningham T, Timmons BW, Courneya KS, Bartels U, Skocic J, de Medeiros C, Liu F, Persadie N, Scheinemann K, Scantlebury N, Szulc KU, Bouffet E, Mabbott DJ. Exercise training for neural recovery in a restricted sample of pediatric brain tumor survivors: a controlled clinical trial with crossover of training versus no training. Neuro Oncol. 2017 Mar 1;19(3):440-450. doi: 10.1093/neuonc/now177.
- Results publication: PubMed 32403066Cox E, Bells S, Timmons BW, Laughlin S, Bouffet E, de Medeiros C, Beera K, Harasym D, Mabbott DJ. A controlled clinical crossover trial of exercise training to improve cognition and neural communication in pediatric brain tumor survivors. Clin Neurophysiol. 2020 Jul;131(7):1533-1547. doi: 10.1016/j.clinph.2020.03.027. Epub 2020 Apr 13.
- Derived from this study: PubMed 40515500Baudou E, Ryan JL, Tseng J, Bouffet E, Bartels U, Timmons BW, de Medeiros CB, Mabbott DJ. Repairing Myelin After Irradiated Pediatric Brain Tumor: A Magnetization Transfer Imaging Analysis. Pediatr Blood Cancer. 2025 Sep;72(9):e31838. doi: 10.1002/pbc.31838. Epub 2025 Jun 14.
- Derived from this study: PubMed 38222057Baudou E, Ryan JL, Cox E, Nham L, Johnston K, Bouffet E, Bartels U, Timmons B, de Medeiros C, Mabbott DJ. Optimizing an exercise training program in pediatric brain tumour survivors: Does timing postradiotherapy matter? Neurooncol Pract. 2023 Sep 9;11(1):69-81. doi: 10.1093/nop/npad055. eCollection 2024 Feb.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donald Mabbott, PhD principal investigator
The Hospital for Sick Children, Toronto Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Program in people with Brain Tumor, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of implementing an excercise intervention (time frame: At week 42-45). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01944761, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.